FDA Data MCP
☰
Docs
Datasets
Pricing
Blog
Account
Statistics
Get API Key
Home
/
510(k) Clearances
/ K834239
510(k) K834239
SDI C-FLEX STERILE LIGHT HANDLE by
Sterile Design, Inc.
Clearance Details
Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 1984
Date Received
December 6, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No
Other clearances by Sterile Design, Inc.
K934688
— STERILE DESIGN (March 16, 1994)
K841960
— CARDIO METRICS INVASIVE PRESSURE MONIT (November 8, 1985)
K842356
— CUSTOM STERILE PROCEDURE KITS (March 21, 1985)
K841959
— CARDIO METRIC CUSTOM PERFUSION TUBING (October 19, 1984)
K842351
— STERILE DESIGN-CUSTOM STERILE IV KIT (October 15, 1984)
K841958
— CARDIO METRICS CARDIOTOMY RESERVOIR (October 15, 1984)
K834237
— GRADUATED GUIDE WIRE BOWL 8 (February 4, 1984)
K813437
— PAN SET (December 31, 1981)
K791738
— CUSTOM DRESSING CHANGE TRAYS (October 2, 1979)